The legal-administrative regime of medicinal products in the digital society era: challenges and opportunities from a Spanish perspective

Abstract

This chapter analyzes the legal framework regulating medicinal products (especially in the stages of research, prescription and dispensation) in the digital society era. Specifically, this work focusses on four problems, connected to each other but differentiated: 1) the prescription of medicinal products through electronic medical prescription (or e-prescription), 2) the purchase of medicinal products through the Internet (e-pharmacies), 3) the dispensation of medicinal products using drones and riders, and 4) the use of big data in the clinical trials of medicinal products. Technological tools of the digital society offer us endless possibilities in order to protect our health. The law cannot ignore the problems that this new scenario also brings, linke self-medication or the acquisition of counterfeit medicines, digital illiteracy and the digital divide, the protection of patient data, the interoperability of computer systems, or the preservation conditions of medicinal products when transported using new technologies. To embrace this technical advance should not imply breaking with our Mediterranean pharmacy model or with the guarantees offered by the fact that the medicinal products move within the official circuit, under the guidance and direction of pharmaceutical professionals.